Weeping balloon catheter

• US 8,034,022 B2
• Filed: 03/25/2009
• Issued: 10/11/2011
• Est. Priority Date: 04/08/2008
• Status: Active Grant

• Current Assignee: Cook Medical Technologies, LLC (Cook Group Incorporated)
• Original Assignee: Cook Medical Technologies, LLC (Cook Group Incorporated)
• Inventors: Boatman, Scott E.
• Primary Examiner(s): Stigell; Theodore
• Assistant Examiner(s): Bosques; Edelmira
• Application Number:
  US12/411,106
• Publication Number:
  US 20090254064A1
• Time in Patent Office: 930 Days
• Field of Search: 604 9601-10314
• US Class Current: 604/96.01
• CPC Class Codes: A61M 2025/1013 with concentrically mounted balloons, e.g. being independently inflatable
• CPC Class Codes: A61M 2025/105 having a balloon suitable for drug delivery, e.g. by using holes for delivery, drug coating or membranes
• CPC Class Codes: A61M 2206/20 having means for promoting or enhancing the flow, actively or passively
• CPC Class Codes: A61M 25/1011 Multiple balloon catheters
• CPC Class Codes: A61M 25/104 used for angioplasty

Abstract

Multiple-balloon catheters, and methods of treatment therewith, are provided including an inflatable inner balloon at least partially enclosed by an expandable outer balloon that has holes. The annular space between the inner balloon and the outer balloon is configured to promote delivery of the fluid evenly through holes in the outer balloon to avoid problems of underloading and/or overloading. Preferably, the annular space is in communication with the holes, and the annular space is configured to receive and then to release and distribute the fluid via the holes in a substantially uniform manner such that even amounts of fluid are released in the distal and proximal holes. The inner balloon may have various configurations including being tapered relative to the outer balloon. The outer balloon may also be tapered accordingly. The device may also include raised portions disposed in the annular space and configured to define channels having various configurations.

Claims

1. A multiple-balloon intraluminal fluid delivery catheter for delivering a fluid into a body vessel comprising:

a catheter shaft extending along a longitudinal axis from a proximal end to a distal end, the catheter shaft including an inflation lumen to deliver an inflation fluid and a fluid delivery lumen to deliver said fluid;

an inner balloon including a middle region having a first end and a second end, the inner balloon mounted on the distal end of the catheter shaft and in communication with the inflation lumen, the inner balloon being movable between a deflated configuration and an inflated configuration;

in the inflated configuration the inner balloon has a uniform taper from the first end to the second end of the middle region; and

an outer balloon mounted around at least a portion of the inner balloon, the outer balloon having a proximal end and a distal end and a middle portion therebetween, the outer balloon being movable between a compressed configuration and an expanded configuration, the outer balloon including a plurality of holes, the inner balloon and the outer balloon being configured and oriented such that an annular lumen is defined when the inner balloon is in the inflated configuration and the outer balloon is in the expanded configuration, the annular lumen being in communication with the fluid delivery lumen and the plurality of holes, the annular lumen being configured to promote the delivery of said fluid through the plurality of holes, wherein the annular lumen has a portion disposed between the middle region of the inner balloon and the middle portion of the outer balloon, the annular lumen portion having an increasingly smaller cross-sectional area along the longitudinal axis in a distal direction.

2. The multiple-balloon catheter of claim 1, where the first end of the middle region of the inner balloon is proximal to the second end of the middle region of the inner balloon, and in the inflated configuration the inner balloon includes an increasingly larger cross- sectional area along the middle region from the first end to the second end.

3. The multiple-balloon catheter of claim 1, where the inner balloon has a maximum cross-sectional area at the second end of the middle region.

4. The multiple-balloon catheter of claim 3, where the second end of the middle region is disposed closer to the distal end of the outer balloon than the proximal end of the outer balloon.

5. The multiple-balloon catheter of claim 1, where in the inflated configuration the inner balloon includes an increasingly larger cross-sectional area along the middle region from the first end to the second end to promote delivery of said fluid evenly through the plurality of holes.

6. The multiple-balloon catheter of claim 1, where in the inflated configuration the middle region of the inner balloon is configured to promote delivery of said fluid evenly through the plurality of holes.

7. The multiple-balloon catheter of claim 1, where the middle portion of the outer balloon is defined between a first end proximal to a second end, where in the expanded configuration the outer balloon includes a tapering surface tapering along the middle portion from the first end to the distal second end of the middle portion.

8. The multiple-balloon catheter of claim 7, where in the inflated configuration the inner balloon includes a tapering surface tapering along the middle region from the first end to the second end of the middle region, wherein the taper of the tapering surface of the outer balloon is greater than the taper of the tapering surface of the inner balloon to promote delivery of said fluid evenly through the plurality of holes.

9. The multiple-balloon catheter of claim 1, where the inner balloon and the outer balloon are independently movable to the inflated configuration and the expanded configuration, respectively.

10. The multiple-balloon catheter of claim 1, where in the inflated configuration the inner balloon has a maximum cross-sectional area at either the first or the second end of the middle region sized to dilate a portion of said body vessel.

11. The multiple-balloon catheter of claim 1, where in the expanded configuration the outer balloon has a maximum cross-sectional area sized to sealably contact a portion of said body vessel.

12. A multiple-balloon intraluminal fluid delivery catheter for delivering a fluid into a body vessel comprising:

a catheter shaft extending along a longitudinal axis from a proximal end to a distal end, the catheter shaft including an inflation lumen to deliver an inflation fluid and a fluid delivery lumen to deliver said fluid;

an inner balloon including a middle region having a first end and a second end, the middle region having a substantially cylindrical shape, the inner balloon mounted on the distal end of the catheter shaft and in communication with the inflation lumen, the inner balloon being movable between a deflated configuration and an inflated configuration; and

an outer balloon mounted around the inner balloon, the outer balloon having a proximal end and a distal end and a middle portion therebetween, where the middle portion is defined between a first end proximal to a second end, the outer balloon being movable between a compressed configuration and an expanded configuration, the outer balloon including a plurality of holes, where the outer balloon has a taper along the middle portion thereof such that the cross-sectional area at the second end of the middle portion is smaller than the cross-sectional area at the first end of the middle portion of the outer balloon,

the inner balloon and the outer balloon being configured and oriented such that an annular lumen is defined when the inner balloon is in the inflated configuration and the outer balloon is in the expanded configuration, the annular lumen being in communication with the fluid delivery lumen and the plurality of holes,

the annular lumen being configured to promote the delivery of said fluid through the plurality of holes, wherein the annular lumen has a portion disposed between the middle region of the inner balloon and the middle portion of the outer balloon, the annular lumen portion having an increasingly smaller cross-sectional area along the longitudinal axis in a distal direction.

13. A multiple-balloon catheter for delivering a therapeutic agent into a body vessel comprising:

a catheter shaft extending along a longitudinal axis from a proximal end to a distal end, the catheter shaft including an inflation lumen to deliver an inflation fluid and a fluid delivery lumen to deliver said therapeutic agent;

an inner balloon including a middle region having a first end and a second end, the inner balloon mounted on the distal end of the catheter shaft and in communication with the inflation lumen, the inner balloon being movable between a deflated configuration and an inflated configuration; and

an outer balloon mounted around the inner balloon, the outer balloon having a proximal end and a distal end and a middle portion therebetween, the middle portion defined between a first end proximal to a second end, the outer balloon being movable between a compressed configuration and an expanded configuration, the middle portion of the outer balloon including a plurality of holes having a cross-sectional area that increases from the first end to the second end of the middle portion,

the inner balloon and the outer balloon being configured and oriented such that an annular lumen is defined when the inner balloon is in the inflated configuration and the outer balloon is in the expanded configuration, the annular lumen being in communication with the fluid delivery lumen and the plurality of holes,

the annular lumen being configured to promote the delivery of said therapeutic agent through the plurality of holes, wherein the annular lumen has a portion disposed between the middle region of the inner balloon and the middle portion of the outer balloon, the annular lumen portion having an increasingly smaller cross-sectional area along the longitudinal axis in a distal direction in order to inhibit overloading of the therapeutic agent at the proximal end of the outer balloon or underloading of the therapeutic agent at the distal end of the outer balloon being delivered to the body vessel.